Migun

GUDID B556HY7770

Provides infrared heat to different areas of the body. It is indicated for the temporary relief of minor muscle and joint pain. the temporary relief o

MIGUN MEDICAL INSTRUMENT CO.,LTD

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: B556HY7770
• NIH Device Record Key: bf6027a5-ee16-4fcb-9279-a14dbbdfcefa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Migun
• Version Model Number: HY777
• Company DUNS: 689266158
• Company Name: MIGUN MEDICAL INSTRUMENT CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B556HY7770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041200

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-01

On-Brand Devices [Migun]

• B556MG36000: The Migun Pain Relief Mat provides infrared heat to different areas of the body. It is indicated
• B556MG33000: The Migun Pain Relief Mat provides infrared heat to different areas of the body. It is indicated
• B556MG31000: The Migun Pain Relief Mat provides infrared heat to different areas of the body. It is indicated
• B556HY7770: Provides infrared heat to different areas of the body. It is indicated for the temporary relief
• B556HY7000UM0: Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeut
• B556HY7000U0: Migun HY7000U is a multi function physio therapy table used primarily for pain relief and to inc
• B556ED3010: The Migun Pain Relief Mat provides infrared heat to different areas of the body. It is indicated